drugset / Trial / NCT04243148
Frailty in Patients With Cirrhosis: Prognostic Value of the Phase Angle in Hospitalized Patients and Effect of Multifactorial Intervention
RandomizedParallel-groupOpen-labelTreatment
Summary
This study evaluate Frailty syndrome (FS) as a common syndrome in patients with cirrhosis and it is an independent predictor of hospitalizations, falls and mortality. Identifying, treating and preventing FS can improve the prognosis and quality of life of these patients and reduce health costs.
Timeline
- Start
- 2020-05-13
- Primary completion
- 2022-06-30
- Completion
- 2023-05-30
Outcome
Met primary endpoint
paper The change in LFI (ΔLFI) at 12 months was -0.71 ± 0.24 in the intervention group and -0.09 ± 0.32 in the control group (p<0.001). PMID 38701490 ↗
paper A long-term multifactorial intervention that included exercise at home, branched-chain amino acids, and a multistrain probiotic improved frailty in outpatients with cirrhosis PMID 38701490 ↗
Publications
- Vega-Abellaneda S, Roman E, Soler Z, Ortiz MA, Rossi G, Biagini L, Sanchez E, Pons-Tarin M, Laghi L, Mengucci C, Kaur N, Poca M, Cuyas B, Serrano-Gomez G, Alvarado E, Manichanh C, Soriano G. A Metagenomics Approach to Frailty in Patients With Cirrhosis Undergoing a Multifactorial Intervention. Liver Int. 2025 Dec;45(12):e70418. doi: 10.1111/liv.70418.
- Roman E, Kaur N, Sanchez E, Poca M, Padros J, Nadal MJ, Cuyas B, Alvarado E, Vidal S, Ortiz MA, Hernandez E, Santesmases R, Urgell E, Juanes E, Ferrero-Gregori A, Escorsell A, Guarner C, Soriano G. Home exercise, branched-chain amino acids, and probiotics improve frailty in cirrhosis: A randomized clinical trial. Hepatol Commun. 2024 May 3;8(5):e0443. doi: 10.1097/HC9.0000000000000443. eCollection 2024 May 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Branched-Chain Amino Acids | Other / unclassified | 10 g | — |
| Subject | Vivomixx | Other / unclassified | 4.5e+11 cells | — |